Empagliflozin cost-effectiveness analysis in Japanese heart failure with mildly reduced and preserved ejection fraction.

AIMS: Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, was shown to be effective in patients with heart failure with preserved ejection fraction (HFpEF) in the EMPEROR-Preserved trial. The present study aims to evaluate the cost-effectiveness of empagliflozin among Japanese patients with HFpEF. METHODS AND RESULTS: A Markov cohort model was developed to evaluate the cost-effectiveness of empagliflozin added to standard of care (SoC) compared with SoC alone in patients with HFpEF from the perspective of the Japanese healthcare system and with a lifetime horizon. In addition to clinical events, the progression of disease severity was modelled based on the migration of Kansas City Cardiomyopathy Questionnaire-Clinical Summary Scores (KCCQ-CSS). Model inputs, including risk of clinical events, costs, and utilities/disutilities, were derived from EMPEROR-Preserved trial data, a claims database and published literature. The generalizability of model results was investigated by applying various subgroups including age, body mass index (BMI), and region Asia, based on the subgroup analysis of EMPEROR-Preserved data. In the base-case analysis, empagliflozin yielded additional quality-adjusted life years (QALYs; 0.11) with an incremental cost of $1408 per patient for Japanese patients with HFpEF. Incremental cost, mainly derived from drug acquisition cost ($1963 per patient), was largely offset by reduced cost in hospitalization for heart failure (HHF) and cardiovascular death (-$537 per patient and -$166 per patient, respectively). Treatment of empagliflozin provided incremental 0.11 QALYs and 0.08 life years compared with SoC alone. The incremental cost-effectiveness ratio (ICER) was $12 772 (¥1 662 689)/QALY, which was below the Japanese willingness-to-pay (WTP) threshold of $38 408 (¥5 000 000)/QALY. The results were consistent across all the subgroups considered, and empagliflozin was dominant over SoC alone in the region Asia and BMI < 25 kg/m2 subgroups. ICERs for the remaining subgroups ranged from $7520/QALY (¥978 972/QALY, patients with baseline age ≥ 75 years) to $31 049/QALY (¥4 041 896/QALY, patients with baseline New York Heart Association class III/IV). Deterministic sensitivity analysis result showed that the treatment effect on HHF is the biggest driver of the cost-effectiveness analysis, while the ICER will be still under the threshold even if no effect of empagliflozin on HHF was assumed. The probabilistic sensitivity analysis result showed that 64% of simulations were cost-effective based on the Japanese WTP threshold. CONCLUSIONS: Empagliflozin was demonstrated to be cost-effective for patients with HFpEF in Japan based on EMPEROR-Preserved trial data.

Prognostic factors affecting survival in patients with non-small cell lung cancer treated with salvage surgery after drug therapy: a multi-institutional retrospective study.

BACKGROUND: The prevalence of salvage surgeries after drug therapy for non-small cell lung cancer (NSCLC) has risen, mainly due to recent progress in molecular-targeted drugs and immune checkpoint inhibitors for NSCLC. While the safety and effectiveness of salvage surgery after drug therapy for NSCLC have been studied, its indications remain unclear. We aimed to identify the prognostic factors affecting survival in patients with advanced-stage (stages III-IV) NSCLC treated with salvage surgery after drug therapy. METHODS: A retrospective investigation was conducted on patients who received salvage surgery after drug therapy at four hospitals between 2007 and 2020. Salvage surgery was defined as surgery after drug therapy for local progression, tumor conversion to resectable status, and discontinuation of prior drug therapy owing to serious complications. RESULTS: Thirty-two patients received cytotoxic agents alone (n = 12 [38%]), tyrosine kinase inhibitors (TKIs; n = 16 [50%]), or immune checkpoint inhibitors (n = 4 [13%]) as prior drug therapy. In 11 (34%) and 21 (66%) patients, the clinical stage before treatment was III or IV, respectively. The median initial and preoperative serum carcinoembryonic antigen (CEA) levels were 10.2 (range, 0.5-1024) ng/mL and 4.2 (range, 0.6-92.5) ng/mL, respectively. Among the patients, 28 (88%) underwent lobectomy, 2 (6%) underwent segmentectomy, and 2 (6%) underwent wedge resection. Complete resection of the primary lesion was accomplished in 28 (88%) patients. Postoperative complications were documented in six (19%) patients. Mortality rates were 0% at 30 days and 3% at 90 days post-operation. The 5-year overall survival rate stood at 66%, while the 5-year progression-free survival rate was 21%. Multivariate analyses showed that prior TKI therapy and preoperative serum CEA level < 5 ng/mL were prognostic factors influencing overall survival (hazard ratio [95% confidence interval]: 0.06 [0.006-0.68] and 0.03 [0.002-0.41], respectively). The 5-year overall survival in the 11 patients with both favorable prognosticators was 100%. CONCLUSIONS: In this study, prior TKI therapy and preoperative serum CEA level < 5 ng/mL were favorable prognostic factors for overall survival in patients with NSCLC treated with salvage surgery. Patients with these prognostic factors are considered good candidates for salvage surgery after drug therapy.

Cost-effectiveness of combination therapy of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisolone for previously untreated diffuse large B-cell lymphoma in Japan.

AIM: The POLARIX trial showed that Pola + R-CHP (polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisolone) prolongs progression-free survival (PFS) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), the conventional standard of care, with a similar safety profile. However, Pola + R-CHP has not been evaluated from the viewpoint of health economics in Japan. This study evaluates the cost-effectiveness of Pola + R-CHP for previously untreated DLBCL from a Japanese public healthcare payer's perspective. METHODS: A partitioned survival analysis model was constructed to estimate lifetime costs and effectiveness of Pola + R-CHP and R-CHOP in previously untreated DLBCL who had an International Prognostic Index score (IPI) score of ≥2. A parametric survival model was applied to data analyzed in the POLARIX trial to estimate the lifetime overall survival (OS) and PFS for each treatment. The parameters required for the model were based on the results of a literature search and expert opinion. RESULTS: The incremental cost-effectiveness ratio (ICER) of Pola + R-CHP vs. R-CHOP was JPY2,710,238 per quality-adjusted life year (QALY), less than the ICER of JPY7.5 million per QALY that is considered to be cost-effective based on the threshold of the Japanese cost-effectiveness evaluation system. One-way sensitivity analysis showed that the parameters influencing the results of the analysis were median PFS and the total cost per regimen of salvage chemotherapy, patient weight, and patient age. Probabilistic sensitivity analysis showed that the probability of Pola + R-CHP having superior cost-effectiveness was 99.2% when the reference value was JPY7.5 million. The results of scenario analysis suggested that prolongation of PFS was an important factor in the evaluation of cost-effectiveness in previously untreated DLBCL with or without prolongation of OS. CONCLUSIONS: This study suggests that Pola + R-CHP is a cost-effective treatment for previously untreated DLBCL in Japan under the public health insurance system.

Prognostic Impact of Visceral Pleural Invasion in Resected Solitary Lung Metastases from Gastric Cancer.

PURPOSE: Pulmonary resection of metastases from gastric cancer is extremely rare because gastric cancer metastasis to the lungs or thoracic cavity occurs as multiple pulmonary metastases, carcinomatous lymphangitis, or carcinomatous pleurisy. Therefore, the significance of surgery for pulmonary metastasis of gastric cancer remains unclear. This study aimed to investigate the surgical outcomes and prognostic factors for survival after the resection of pulmonary metastases from gastric cancer. METHODS: From 2007 to 2019, 13 patients with pulmonary metastasis of gastric cancer underwent metastasectomy. Surgical outcomes were analyzed to determine the prognostic factors for recurrence and overall survival (OS). RESULTS: All the patients underwent pulmonary resection for solitary metastases. At the median follow-up time of 45.6 months (range, 4.8-106.8 months), five patients experienced a recurrence of gastric cancer after metastasectomy. The 5-year recurrence-free survival rate was 44.4%, and the 5-year OS rate after pulmonary resection was 45.3%. Univariate analysis revealed that visceral pleural invasion (VPI) was an unfavorable prognostic factor for both recurrence-free and OS. CONCLUSION: Pulmonary resection of solitary metastases from gastric cancer may be an effective therapeutic option to improve survival. VPI in gastric cancer metastasis is a negative prognostic factor.

Budget impact analysis of comprehensive genomic profiling for untreated advanced or recurrent solid cancers in Japan.

AIMS: In Japan, the use of comprehensive genomic profiling (CGP) is only available for cancer patients who have no standard of care (SoC), or those who have completed SoC. This may lead to missed treatment opportunities for patients with druggable alterations. In this study, we evaluated the potential impact of CGP testing before SoC on medical costs and clinical outcome in untreated patients with advanced or recurrent biliary tract cancer (BTC), non-squamous non-small cell lung cancer (NSQ-NSCLC), or colorectal cancer (CRC) in Japan between 2022 and 2026. MATERIALS AND METHODS: We constructed a decision-tree model reflecting the healthcare environment of Japan, to estimate the clinical outcome and medical costs impact of CGP testing by comparing two groups (with vs without CGP testing before SoC). The epidemiological parameters, detection rates of druggable alterations, and overall survival were collected from literature and claims databases in Japan. Treatment options selected based on druggable alterations were set in the model based on clinical experts' opinions. RESULTS: In 2026, the number of untreated patients with advanced or recurrent BTC, NSQ-NSCLC, and CRC was estimated to be 8600, 32,103, and 24,896, respectively. Compared with the group without CGP testing before SoC, CGP testing before SoC increased druggable alteration detection and treatment rate with matched therapies in all three cancer types. The medical costs per patient per month were estimated to increase with CGP testing before SoC in the three cancer types by 19,600, 2900, and 2200 JPY (145, 21, and 16 USD), respectively. LIMITATIONS: Only those druggable alterations with matched therapies were considered in the analysis model, while the potential impact of other genomic alterations provided by CGP testing was not considered. CONCLUSIONS: The present study suggested that CGP testing before SoC may improve patient outcomes in various cancer types with a limited and controllable increase in medical costs.

Cost-effectiveness analysis of empagliflozin in patients with heart failure with reduced ejection fraction in Japan based on the EMPEROR-Reduced trial.

BACKGROUND: Several studies have reported the cost-effectiveness of sodium-glucose co-transporter 2 inhibitors in heart failure patients; however, their economic implications have not been sufficiently elucidated in Japan. METHODS: A Markov cohort model was developed to evaluate the cost-effectiveness of empagliflozin plus standard of care (SoC) vs. SoC for patients with heart failure with reduced ejection fraction (HFrEF) in Japan. Model inputs, including risk of clinical events, costs, and utilities based on Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores were derived from EMPEROR-Reduced trial data, published literature, and a claims database. RESULTS: The model predicted lower lifetime hospitalizations for heart failure (HHFs) and additional quality-adjusted life-years (QALYs; 0.21) for empagliflozin plus SoC vs. SoC in the overall population. Increased costs of ¥100,495/patient ($772/patient), primarily driven by higher drug costs of ¥239,558/patient ($1,840/patient), were largely offset by reduced HHF management costs of -¥166,160/patient (-$1,276/patient), yielding an incremental cost-effectiveness ratio (ICER) of ¥469,672/QALY ($3,608/QALY). Results were consistent among subgroups and sensitivity analyses. In probabilistic sensitivity analysis, 82.5 % of runs were below the Japanese ICER reference value of ¥5,000,000/QALY ($38,408/QALY). CONCLUSIONS: Empagliflozin was demonstrated to be cost-effective for HFrEF patients in Japan based on the EMPEROR-Reduced trial data.

[Relationship between volunteer group participation and depressive symptoms in older Japanese: A 3-year JAGES longitudinal study using propensity score matching].

Objectives　In this study, we aim to clarify the optimal threshold for the frequency of volunteer group participation among older people aged 65 years and above, which is expected to prevent the risk of developing depression.Methods　We utilized longitudinal data from 2013 to 2016, collated by the Japan Gerontological Evaluation Study for people aged ≥65 years living in 24 municipalities and not certified as requiring long-term care. In addition, those who were not depressed in 2013 (≥5 points on the Geriatric Depression Scale-15) were followed up for 3 years and classified according to the frequency of participation in the volunteer group in 2013 (≥once per year, ≥once per month, ≥once per week). The odds ratio (OR) of being newly depressed in 2016 was determined using the propensity score matching method and t-test.Results　The frequency of volunteer group participation for 9,722 (25.0%), 6,026 (15.5%), and 2,735 (7.0%) older individuals was≥once per year, once per month, and once per week, respectively. A comparison of the balanced attributes of the volunteer group participation with those of the non-participation group using propensity scores revealed that the risk of developing depressive symptoms was significantly lower in the former compared with the latter for the frequency of ≥once per month and OR of 0.82 (95% confidence interval: 0.72, 0.93). The ORs were 0.92 (0.83, 1.02) and 0.82 (0.68, 1.00) for the ≥once per year and once per week groups, respectively.Conclusion　Older people's participation in a volunteer group ≥once per month was effective in reducing the risk of developing depressive symptoms after 3 years. This suggests that increasing the opportunities and community places where older people can be involved as volunteers even once a month may be employed as an effective measure to prevent depression.

Community-Level Participation in Volunteer Groups and Individual Depressive Symptoms in Japanese Older People: A Three-Year Longitudinal Multilevel Analysis Using JAGES Data.

BACKGROUND: The current study aimed to investigate the contextual effect of volunteer group participation on subsequent depressive symptoms in older people. METHODS: We analyzed the longitudinal data of 37,552 people aged 65 years and older in 24 municipalities surveyed in the Japan Gerontological Evaluation Study. Volunteer group participation of older people was assessed in 2013 by one question and depressive symptoms were assessed by the Geriatric Depression Scale 15 in 2016. To investigate a contextual effect, we aggregated individual-level volunteer group participation by each residence area as a community-level independent variable. We conducted a two-level multilevel Poisson regression analysis using the Random Intercepts and Fixed Slopes Model. RESULTS: The average proportion of community-level volunteer group participation was 10.6%. The results of the Poisson regression analysis showed that community-level volunteer group participation reduced the risk for the onset of depressive symptoms by 13% with a 10 percentage point increase in participation, after adjusting for sex, age, population density, total annual sunshine hours and annual rainfall (incident rate ratio, 0.87; 95% confidence interval, 0.78-0.98). CONCLUSIONS: Older people living in areas with higher volunteer group participation had a lower risk of developing depressive symptoms regardless of whether or not they participated in a volunteer group.

Burden of caring for Alzheimer's disease or dementia patients in Japan, the US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey.

AIMS: The growing prevalence of Alzheimer's disease (AD) worldwide has sparked the implementation of national policies to support the growing burden among caregivers of AD/dementia patients. This study aims to quantify and compare the burden of AD/dementia caregivers and evaluate how different living arrangements might impact health outcomes among caregivers in Japan, five European countries (5EU), and the United States (US). MATERIALS AND METHODS: This is a cross-sectional study based on existing data from the 2018 National Health and Wellness Survey. Health outcome measures included health-related quality of life (HRQoL), health state utilities, work productivity and activity impairment (WPAI), and measurement of depression and anxiety amongst AD/dementia caregivers and non-caregivers. Pairwise comparisons between AD/dementia caregivers in Japan, 5EU, and the US were conducted. Multivariate analysis was used to compare across groups within each region, with adjustment for potential confounding effects. RESULTS: A higher proportion of caregivers of AD/dementia patients in Japan were 65 years or older as compared to 5EU and US. On the contrary, female caregivers were significantly higher in the US than Japan and 5EU. The HRQoL and health state utilities index scores amongst AD/dementia caregivers were highest in Japan and lowest in the US. Caregivers in Japan incurred the lowest WPAI among the three regions. The proportion of AD/dementia patients reportedly living in an institution was highest in Japan as compared to the US and EU. Notably, US caregivers whose patients lived in an institution experienced significantly less caregiving burden as compared to caregivers whose patients lived in the community. CONCLUSIONS: The caregiving burden among AD/dementia caregivers was substantial across the three regions, with similarities and differences between the West and Japan. The lower caregiving burden in Japan was potentially associated with national policies supporting long-term healthcare and institutionalized nursing care facilities for AD/dementia patients.

Humanistic burden among caregivers of patients with Alzheimer's disease or dementia in Japan: a large-scale cross-sectional survey.

AIMS: As the population in Japan is rapidly aging, the prevalence of dementia, particularly Alzheimer's Disease (AD), is expected to increase, resulting in a growing need for caregivers. This study aims to quantify and compare the humanistic burden of caregivers of AD/dementia patients with caregivers of patients with other conditions in Japan. MATERIALS AND METHODS: This cross-sectional study used data from the 2018 Japan National Health and Wellness Survey (NHWS). Outcome measures included the Short-Form 12-item Health Survey (SF-12) for health-related quality-of-life (HRQoL), EuroQol 5-dimension scale (EQ-5D) for health states utilities, impact of health on productivity and activity, and evaluation of depression and anxiety. Multivariate analysis was used to compare across groups, with adjustment for potential confounding effects. RESULTS: A total of 805 caregivers of AD/dementia patients, 1,099 other caregivers, and 27,137 non-caregivers were identified. Both AD/dementia caregivers and other caregivers had lower HRQoL and EQ-5D scores, higher total activity impairment, and more caregivers tended to experience anxiety than non-caregivers. There were no significant differences in the involvment in basic and instrumental activities of daily living (ADL) between AD/dementia caregivers and caregivers of other conditions. Notably, AD/dementia caregivers were more involved in making treatment decisions and finance management than other caregivers. Among AD/dementia caregivers caring for one patient, 395 patients lived in the community and 282 in an institution. AD/dementia caregivers whose patients lived in the community were more significantly involved in basic and instrumental ADL. Caregivers of patients with both AD/dementia and cancer had higher caregiving burden than caregivers of patients with either condition. CONCLUSIONS: Caregivers of AD/dementia patients in Japan reportedly experienced significant humanistic burden which is associated with patients' living arrangements and the presence of an additional chronic condition. Therefore, provision of effective care/support is essential to relieve the burden experienced by the caregivers.

Factors associated with humanistic burden and indirect cost among patients with cancer in Japan.

AIMS: Patients with cancer experienced reduced health-related quality-of-life (HRQoL), increased work productivity and activity impairment (WPAI), and indirect costs. With the current emphasis on economic evaluation of health technology in Japan, it is important to understand how indirect costs correlate with HRQoL and patient characteristics. It is also crucial to assess the patient characteristics associated with the HRQoL, WPAI, and indirect costs among patients with any types of cancer. MATERIALS AND METHODS: This cross-sectional study used data from the 2017 Japan National Health and Wellness Survey (NHWS). Respondents self-reported their HRQoL and WPAI by answering validated SF-12v2 and WPAI questionnaires, respectively. Indirect costs were derived using the human capital method. Correlation between HRQoL components and indirect costs were assessed using Spearman's rank-order correlation. Correlation between patient characteristics and HRQoL, WPAI, and indirect costs were analyzed using generalized linear models. RESULTS: A total of 1,540 patients with any types of cancer, 254 with breast cancer, and 144 with colorectal cancer were included in the analyses. There was significant negative correlation between the indirect costs and HRQoL components among patients with any types of cancer. Patients with lower comorbid burden, higher household income, employed, married, or living with partner, never smokers, and exercised tended to have higher HRQoL. Being never smokers, having lower comorbid burden, normal weight, and exercised were associated with lower WPAI measures. Additionally, patients who were older, not married, not obese, and not smoking tended to incur lower indirect costs. CONCLUSIONS: The negative correlation between HRQoL and indirect costs among patients with cancer emphasized the needs to improve health outcomes and reduce indirect costs of patients. The factors associated with cancer burden identified in this study provide insights to allow targeted intervention to improve HRQoL and lessen the WPAI and indirect cost among cancer patients in Japan.

Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINA® Trial.

INTRODUCTION: We evaluated the cost-effectiveness of linagliptin in Japan by estimating the lifetime outcome based on clinical event rates from the Asian subpopulation of the CARMELINA trial. In CARMELINA, linagliptin added to standard of care (SoC) versus SoC demonstrated noninferiority with regard to risk of composite cardiovascular (CV) outcome in patients with type 2 diabetes at high risk of CV and kidney events. Issues resulting from conducting a cost-effectiveness analysis using data from a clinical noninferiority study were also investigated. METHODS: A microsimulation model was used to evaluate linagliptin/SoC versus SoC in terms of direct costs and quality-adjusted life years (QALYs) from a Japanese public healthcare payer's perspective. Cost data were obtained from recent Japanese publications. The time horizon was defined as lifetime, and the discount rate for costs and effectiveness was 2% per year. One-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case analysis, and taking medical history into account, the incremental effectiveness of linagliptin/SoC versus SoC was 1.34 QALYs, and the incremental cost for linagliptin was - 545,319 yen. In the one-way sensitivity analysis, the parameter which most affected the results was the hazard ratio for renal failure of linagliptin/SoC compared with SoC. The probabilistic sensitivity analysis showed that the probability of reduced costs and increased effectiveness (dominant) was 48%. Assuming an incremental cost-effectiveness ratio (ICER) threshold of 5 million yen, the probability that the ICER was below the threshold was 89% for linagliptin/SoC compared with SoC. CONCLUSIONS: This evaluation, using Asian subpopulation data from the CARMELINA trial, suggested that the cost-effectiveness of linagliptin for a lifetime outcome was favourable in Japan. However, the results must be interpreted cautiously because of the noninferiority trial data source, which might cause ICER variations for each parameter.

Humanistic and economic burden among caregivers of patients with cancer in Japan.

Aims: As the number of cancer patients increases in Japan, and people are living longer with cancer, the need for caregivers of cancer patients is expected to increase substantially. This study intended to reveal the humanistic and economic burden among caregivers of cancer patients, and to compare it with the burden among caregivers of patients with other conditions (other caregivers) and non-caregivers.Materials and methods: This cross-sectional analysis used data from the Japan National Health and Wellness Survey 2017. Outcome measures included the Short Form 12-item Health Survey for health-related quality of life (HRQoL), EuroQol 5-dimension scale (EQ-5D) for health states utilities, Work Productivity and Activity Impairment questionnaire for the impact of health on productivity and activity, and indirect costs. Multivariate analysis was used to compare across groups, with adjustment for potential confounding effects.Results: A total of 251 caregivers of cancer patients, 1,543 other caregivers, and 27,300 non-caregivers were identified. Caregivers of cancer patients (average 48.0 years old) tended to be younger than non-caregivers (51.5) and other caregivers (54.4) and had the highest education level (57.8% completed university education). Fewer non-caregivers had stress-related comorbidities than caregivers. Non-caregivers had significantly higher EQ-5D index scores than caregivers (average 0.81 vs. 0.73 vs. 0.74). Caregivers of cancer patients had significantly lower mental component summary scores than non-caregivers (40.18 vs. 46.70), and the difference indicated a clinically meaningful decrease in HRQoL. Caregivers of cancer patients had significantly higher presenteeism (37.31% vs. 20.43%), total work productivity impairment (38.85% vs. 21.98%), and activity impairment (40.94% vs. 25.78%) than non-caregivers. Additionally, caregivers of cancer patients had significantly higher total indirect costs (36.34% vs. 20.03% of average annual income).Conclusions: These results have implications for future healthcare planning, suggesting the importance of healthcare systems in Japan to consider the substantial burden borne by caregivers of cancer patients.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

Tracheal resection and reconstruction for post-tracheostomy tracheal stenosis treated with T-tube stenting for 10 years.

We describe the case of a patient who underwent tracheal resection for post-tracheostomy stenosis following T-tube stenting for 10 years. A 32-year-old female patient with a T-tube in the trachea was referred to us. She had brain surgery for intracranial hemorrhage 10 years ago and developed a post-tracheostomy tracheal stenosis, for which she had been treated with a T-tube. At the time of referral, she was ambulatory with a cane and otherwise independent in her daily life. We assessed her stenosis and determined that it was amenable to tracheal resection as a definitive treatment. We resected the tracheal stenosis including the stoma site and performed an end-to-end tracheal anastomosis. The anastomosis was widely patent at 6 months follow-up. Long-term treatment of tracheal stenosis with T-tube does not preclude tracheal resection as a definitive treatment. A careful review of airway stenosis for resectability on a case-by-case basis is imperative.

A population-based study of the humanistic burden among cancer patients in Japan.

Aims: Understanding the burden of cancer in Japan is becoming increasingly important to address the socio-economic consequences of the disease. This study broadly examined the cancer burden in terms of: Health-Related Quality of Life (HRQoL), work productivity and activity impairment (WPAI), stress-related comorbidities, and indirect costs in patients diagnosed with (i) any type of cancer, (ii) breast cancer, (iii) colorectal cancer, compared to controls without cancer.Materials and methods: This cross-sectional study used data from the 2017 Japan National Health and Wellness Survey (NHWS). Patient outcomes included self-reported stress-related comorbidities, HRQoL assessed by Short Form 12-item Health Survey and EuroQoL 5-dimension scale (EQ-5D), and work productivity and indirect costs assessed by WPAI questionnaire. Multivariate analysis was performed to compare outcomes across groups. An ad-hoc analysis compared respondents currently and currently not receiving prescription medication (Rx).Results: A total of 1,540 patients with any type of cancer, 254 with breast cancer, 144 with colorectal cancer were included in the analyses and compared to 28,070 controls without cancer. After adjusting for potential confounding effects patients with any type of cancer had significantly lower mental component summary scores (45.70 vs. 46.45, p = .003), physical component summary scores (48.95 vs. 50.02, p < .001) and EQ-5D index (0.77 vs. 0.79, p < .001), and significantly increased absenteeism (5.13% vs. 2.68% p < .001) compared to controls. No significant differences were detected for indirect costs. Breast cancer patients had significantly increased odds of anxiety and migraine. Colorectal cancer patients had significantly increased odds of insomnia. Patients currently receiving Rx had significantly lower HRQoL and higher WPAI than both controls and cancer patients not receiving Rx.Conclusions: Japanese cancer patients experience a significantly decreased HRQoL, increased absenteeism and higher odds ratio for stress-related comorbidities. This has implications for future policy making and Health Technology Assessment in Japan.

Cost-effectiveness analysis of percutaneous mitral valve repair with the MitraClip delivery system for patients with mitral regurgitation in Japan.

Aims: The objective of the study is to evaluate the cost-effectiveness of percutaneous mitral valve repair (TMVr) with the MitraClip NT system (MitraClip procedure) for patients with symptomatic severe mitral regurgitation (MR) at high surgical risk in line with the methodological guideline for cost-effectiveness evaluation by the Ministry of Health, Labour and Welfare.Material and Methods: The cost-effectiveness of MitraClip procedure was evaluated using a Markov model. Patients are classified into four New York Heart Association classes in each cycle. The model considered MitraClip complication ("major vascular complication", "major bleeding complication", "non-cerebral thromboembolism"), adverse events, re-implantation with MitraClip device, mitral valve surgery, and congestive heart failure hospitalization. For the evidence on additional benefits, a study compared with propensity score-matched medical therapy group was used in the analysis. The analysis was conducted from the perspective of a public healthcare payer with a discount rate of 2% for both cost and effectiveness.Results: In the base-case analysis, total cost and quality-adjusted life year (QALY) gained (Life year (LY) gained) were 7,541,151 JPY and 3.23 QALYs (3.85 LYs) for MitraClip group, and 4,699,692 JPY and 1.79 QALYs (2.43 LYs) for medical therapy group, respectively. The incremental cost-effectiveness ratio (ICER) of MitraClip procedure versus medical therapy was 1.97 million JPY/QALY (US$18,570/QALY, US$1 = 106 JPY), which was evaluated to be cost-effective. The probability of ICER of MitraClip procedure versus medical therapy being 5 million JPY/QALY was 96.7%.Limitations: There are two limitations. Firstly, the parameters for the comparators were based on some assumptions. However, it was a conservative setting against MitraClip group. Secondary, the mortality rate and adverse events of MitraClip group in a lifetime were estimated from data during a year after the procedure.Conclusions: MitraClip procedure improved life-years and quality of life in patients at high surgical risk and it was also a cost-effective treatment option.